KR20240035094A - Continuous Anaylyte Measurement Device With Tansmitter - Google Patents

Abstract

The present invention provides an electrochemical sensor that invades into the skin; It includes a main board to which a battery is connected and a housing to accommodate the main board, the housing being attached to the skin, and the main board comprising: a transmitter that controls the measured signal of the electrochemical sensor; A needle that guides the electrochemical sensor to invade into the skin; wherein the transmitter or needle is moved from a first position to a second position to penetrate the user's skin, the proximal portion of the electrochemical sensor is electrically connected to the main substrate, and the distal portion of the electrochemical sensor is electrically connected to the main substrate. A continuous analyte measuring device may be provided that is inserted into the skin together with a needle, and the housing is formed with a depression rather than a closed curved surface through which the needle passes and is aligned.

Description

Continuous Anaylyte Measurement Device With Tansmitter}

The present invention relates to a continuous analyte measuring device comprising an electrochemical sensor that penetrates into the body and continuously measures an analyte and a transmitter having a recess.

When using the inserter as a reference position, one end of the electrochemical sensor connected to the main board is located close to the inserter and can be called the proximal portion, and the other end of the electrochemical sensor inserted into the body is located far from the inserter. It can be called distal.

The proximal portion of the electrochemical sensor may be electrically connected to the main board of the transmitter, and at least a portion of the distal portion of the electrochemical sensor may be inserted into the body. The proximal portion and the distal portion may be located at opposite ends. The proximal portion of the electrochemical sensor may be electrically connected to the main board of the transmitter, which includes the electrical circuitry necessary for measuring analytes, including glucose.

The transmitter may be placed inside the insert along with an electrochemical sensor before being attached to the skin. A type in which a transmitter and an electrochemical sensor are pre-combined can be called an all-in-one type transmitter.

The transmitter is in signal communication with the sensor, wherein the sensor is configured to detect and measure the patient's glucose level for a predetermined period of time and to transmit data corresponding to or related to the measured glucose level for a predetermined period of time for further analysis. .

Since various electronic components, including sensors, are installed in the transmitter and are attached to the skin for a long time, errors may occur if analytes or body fluids seep into the interior of the transmitter.

The present invention provides a continuous analyte measuring device in which a transmitter is provided with a recessed portion having an opening on the outer surface, and a needle and part of an electrochemical sensor can be exposed and disposed through the recessed portion.

The transmitter of the present invention has a structure that does not form a through hole through which the needle that penetrates and separates into the body's skin is passed, so it is easy to waterproof and can move the needle without frictional resistance when separating it from the skin. .

The present invention provides an alignment part in the recessed part to automatically align the needle and needle holder, and allows it to move stably without shaking when moving.

The continuous analyte measuring device of the present invention includes an electrochemical sensor that penetrates into the skin; It includes a main board to which a battery is connected and a housing to accommodate the main board, the housing being attached to the skin, and the main board comprising: a transmitter that controls the measured signal of the electrochemical sensor; A needle that guides the electrochemical sensor to invade into the skin; wherein the transmitter or needle is moved from a first position to a second position to penetrate the user's skin, the proximal portion of the electrochemical sensor is electrically connected to the main substrate, and the distal portion of the electrochemical sensor is electrically connected to the main substrate. A continuous analyte measuring device may be provided that is inserted into the skin together with a needle, and the housing is formed with a depression rather than a closed curved surface through which the needle passes and is aligned.

A needle holder may be coupled to one side of the needle.

Centering means may be provided to regulate the coupling position of the needle holder with respect to the transmitter.

Rotation prevention means may be provided to regulate rotation of the needle holder relative to the transmitter.

The centering means or rotation preventing means may be provided in at least one of a recessed portion of the transmitter and the needle holder.

In the conventional embodiment in which the through hole of the needle is formed in the upper lid and the lower lid of the transmitter, when inserted, the needle sequentially passes through the through hole formed in the upper lid of the transmitter and the through hole formed in the lower lid, and when disconnected, the needle passes through the through hole formed in the upper lid of the transmitter and vice versa. It passes through the through hole in the following order and is separated from the transmitter. The electrochemical sensor is exposed to a through hole to align with the needle.

At this time, an outer sealing member is required at the joint between the upper lid and lower lid located on the outer periphery of the transmitter, an inner sealing member is required at the joint between the upper lid and lower lid located at the through hole, and an electrochemical sensor is transmitted through the through hole. A sensor sealing member may be required in the exposed area.

Since the present invention eliminates the through hole through which the needle passes, one outer sealing member is sufficient and an inner sealing member is not necessary. Additionally, there is no need for pillar structures of the upper and lower lids to form through holes. If the conventional through hole and the pillar structure at the through hole location are eliminated, the internal space of the transmitter is greatly expanded even if the transmitter has the same diameter. The expanded space can extend the service life and reduce the user's cost burden by installing a large capacity battery. On the other hand, it is possible to achieve optimized arrangement of electronic components and design freedom of the main board, which can also contribute to improved performance.

Placing electronic components such as batteries and communication units in a coin-sized transmitter avoiding through-holes can ultimately cause inefficiency in circuit design and even cause defects in the electrical connection between the proximal part of the sensor and the main board.

The present invention eliminates through holes, so component placement and electrical connectivity can be greatly improved.

Additionally, since the sensor must be exposed through a narrow through hole, it may be difficult to assemble the sensor into the transmitter. The sensor may bend sharply in the through hole. In the present invention, since the exposed hole of the sensor is located in the recessed part of the transmitter, it corresponds to the outer periphery of the transmitter and the sensor can be exposed to the outside without bending the folded part of the sensor too much, thereby suppressing sensor assembly defects on the transmitter assembly line. .

In addition, when the sensor is exposed around a conventional through hole, there is a problem that waterproofing measures must be taken for the sensor exposure hole in the area where a sharp curvature is formed. A sharply curved sensor exposure hole can cause sealing failure. In the present invention, the through hole is eliminated and the sensor exposure hole is formed in the recessed part of the transmitter corresponding to the outer periphery of the transmitter, so the sealing member can be installed in a gently curved part and the adhesion of the sealing member to the sensor exposure hole can be improved. there is. It is also possible to prevent defects in which the sealing member protrudes outside the through hole.

On the other hand, by omitting the through hole, the outer peripheral design of the transmitter can be freely designed. Since the transmitter is attached to the human body, it is necessary to continuously check the insertion status of the sensor despite the user's activities. Even when measurement data deviates from expectations, user satisfaction can be achieved if the sensor insertion status can be visually confirmed.

The insertion state of the skin and sensor cannot be observed with the naked eye through a conventional narrow through hole, but in the present invention, the insertion position of the skin and sensor is formed on the outer periphery of the transmitter or in the recess of the transmitter, making it easy to visually check the insertion state. can do. It is also possible to check whether body fluid or blood is leaking or whether inflammation has occurred at the sensor insertion site.

In addition, since the needle holder can be brought into contact with the depression at three or more points, the present invention can facilitate the concentric axis alignment of the sensor already assembled in the transmitter and the needle being raised and lowered with respect to the transmitter.

Additionally, since the needle holder is supported in the recessed part of the transmitter, when the transmitter and the needle are lowered and the needle is inserted into the skin, the recessed part holds the needle holder, allowing a hole to be made vertically in the skin. It may contribute to pain relief.

Two types of alignment of the needle to the recess in the transmitter may be required. One is a centering means that aligns and regulates the assembly position of the electrochemical sensor and needle. Another is an anti-rotation means that prevents rotation of the needle relative to the transmitter.

In the present invention, a centering means or a rotation prevention means is provided in the recessed portion of the transmitter or the needle holder.

1 is a cross-sectional side view of the inserter and transmitter of the present invention.
Figure 2 is a perspective view showing the arrangement of the needle and electrochemical sensor according to the present invention.
Figure 3 is a combined perspective view of the transmitter of the present invention.
Figure 4 is a plan view of Figure 3.
Figure 5 is a cross-sectional perspective view taken along line AA of Figure 4.
Figure 6 is a cross-sectional view taken along line AA of Figure 4.
Figure 7 is a plan view of the housing forming the transmitter of the present invention.
Figure 8 is an enlarged view of part B of Figure 7.
Figure 9 is a plan cross-sectional view of the transmitter of the present invention with the upper surface of the upper lid removed.
Figure 10 is a front view of the transmitter of the present invention.
Figure 11 is a longitudinal cross-sectional view of Figure 10.
Figure 12 is an exploded perspective view of the transmitter of the present invention.
Figure 13 is an exploded perspective view of the bottom of the transmitter of the present invention.
Figure 14 is a schematic plan view of the transmitter of the present invention, a diagram for explaining the alignment position relationship between the needle and the electrochemical sensor.

Hereinafter, the case where the electrochemical sensor 400 of the present invention is used in a continuous glucose monitoring system (CGMS) that measures interstitial fluid or blood glucose concentration will be described as an example. However, the continuous blood glucose device of the present invention is not limited to measuring glucose concentration in the body and can be expanded to a continuous analyte meter that measures other biomarkers.

Figure 1 is a side cross-sectional view of the inserter and transmitter of the present invention, and Figure 2 is a perspective view showing the arrangement of the needle and electrochemical sensor according to the present invention.

Referring to Figures 1 and 2, the electrochemical sensor 400 of the present invention can be attached to the skin together with the transmitter 200. The transmitter 200 can control the signal measured by the electrochemical sensor 400 and can transmit continuously measured blood sugar levels to an external terminal, including a mobile phone.

The external terminal is provided separately from the transmitter 200 attached to the skin, and can continuously receive measurement data of the electrochemical sensor 400 wirelessly from the transmitter 200. Users can continuously monitor and diagnose measurement data from the electrochemical sensor 400 for biomarkers including glucose, lactate, etc.

The electrochemical sensor 400 and the transmitter 200 may be provided to the user while being loaded into the inserter 100 before attachment to the skin. By the user's attachment action, the electrochemical sensor 400 and the transmitter 200 may be separated from the inserter 100 and attached to the skin.

One end of the electrochemical sensor 400 connected to the electrical components of the transmitter 200 including the main board 202 may be referred to as the proximal portion 402, and at least a portion of the electrochemical sensor 400 that invades the body The other end can be called the distal part 406, and the proximal part 402 and the distal part 406 are interconnected, and the flexible bent part is called the folded part 405. can do.

Invasion may mean inserting at least a portion of the distal portion 406 of the electrochemical sensor 400 into the body.

The transmitter 200 and the electrochemical sensor 400 may be provided to the user in a state that is already connected to each other before attachment to the skin.

The transmitter 200 is located in the first position while loaded in the inserter 100, and the transmitter 200 moves from the first position to the second position by the user's action. At the second position, the transmitter 200 It may adhere to the skin. The insertion direction of the transmitter 200 and the electrochemical sensor 400 may be from the first position to the second position.

The needle 300 has a portion exposed in the longitudinal direction, and a portion of the electrochemical sensor 400 may be disposed inside the needle 300. The needle 300 may incise the skin and guide the electrochemical sensor 400 so that at least a portion of the distal portion 406 can be invaded into the human body along the insertion direction.

The inserter 100 includes a drive unit 102 that operates the transmitter 200 and the electrochemical sensor 400 from the first position to the second position or returns the needle 300 from the second position to the third position. can do.

The drive unit 102 may advance the needle 300 or the transmitter 200 from a first position to a second position such that the needle 300 or the distal portion 406 is inserted into the skin.

The drive unit 102 attaches the transmitter 200 and the electrochemical sensor 400 to the skin in the second position, and then retracts the needle 300 from the second position to the third position to move the needle 300 to the transmitter 200. ) and can be separated from the electrochemical sensor 400.

The driving unit 102 may be connected to the needle holder 310 on which the needle 300 is fixed. The needle holder 310 can be attached to or detached from the driving unit 102.

Referring to FIG. 3, the transmitter 200 may include an upper lid 210 and a lower lid 220, and an internal space may be provided between the upper lid 210 and the lower lid 220. The main board 202 may be seated in the internal space of the transmitter 200.

A plurality of locking protrusions 211 are formed on the edge of the outer peripheral surface of the upper lid 210 at intervals along the circumferential direction, and a plurality of locking protrusions 211 are detachably coupled to the edge of the outer peripheral surface of the lower lid 220. A locking groove 221 may be formed.

The main board 202 includes a power supply such as a battery required to measure the glucose concentration in the distal part 406, a control unit including an electric circuit, and a control unit for controlling and wirelessly transmitting data measured by the electrochemical sensor 400 to the outside. At least one of a wireless communication unit and an operational amplifier may be installed.

The power supply may supply a bias voltage that can cause an electrochemical reaction of the working electrode.

The analyte signal measured at the distal portion 406 may be amplified by an operational amplifier.

The magnitude of the output current for a given bias on the working electrode may be a measure of the concentration of an analyte, such as glucose, in the vicinity of the electrode.

A control unit comprising an electrical circuit may control the electrical potential between the working electrode and the reference electrode at one or more preset values.

One side of the electrochemical sensor 400 on which the sensor pad is formed may face the main board 202, and the other side of the electrochemical sensor 400 may be exposed to the internal space of the transmitter 200.

A sensor pad may be formed on the proximal portion 402 of the electrochemical sensor 400. A contact pad electrically connected to the sensor pad may be formed on the main board 202.

Since at least a portion of the electrochemical sensor 400 invades into the skin, it can be flexible to relieve pain upon invasion and reduce foreign body sensation when worn.

The distal portion 406 of the electrochemical sensor 400 may be disposed on an exposed portion along the longitudinal direction of the needle 300. The end of the needle 300 is in a more protruding position than the end of the distal portion 406. The distal portion 406 of the electrochemical sensor 400 may be inserted into the body after the skin is incised by the needle 300.

Reduction of pain and foreign body sensation are the core performance of continuous analyte meters from the user's perspective. To this end, the electrochemical sensor 400 has flexibility that makes it impossible to penetrate the skin alone, and the electrochemical sensor 400 is thin and flexible enough to be inserted into the body only when the needle 300 incises the skin.

As previously described, the transmitter 200 may include a housing including an upper lid 210 and a lower lid 220. The main board 202 may be provided inside the housing, and the lower lid 220 may be attached to the user's skin.

Here, according to the biggest technical feature of the present invention, closed curved through holes through which the needle 300 passes are not formed on the upper and lower surfaces of the housing.

Referring to FIGS. 3 and 4 , a depression 204 may be formed on one side of the upper lid 210 and the lower lid 220, which is not a closed curved surface but a partially open curved surface. Forming the closed curved surface may be in the form of a hole (or hole), and this type of hole may be a structure that is not provided in the transmitter 200 of the present invention. Accordingly, the transmitter 200 may have a shape without a hole through which the needle 300 passes, regardless of which side of the housing (side, plane, bottom) is viewed.

An opening 205 may be formed in a portion of the depression 204.

The recessed portion 204 may include an alignment portion 204a formed at an inner position and corresponding to the opposite side of the opening 205, and a side portion 204b corresponding to both sides of the opening 205.

The alignment portion 204a may be formed to be larger than the opening width of the side portion 204b, and may serve to prevent the needle holder 310 from passing through, and the needle holder 310 may be seated on the alignment portion 204a. When this happens, the placement positions of the needle 310 and the needle holder 310 in the transmitter 200 can be automatically aligned.

Additionally, the alignment portion 204a may be formed to be approximately oval in plan view, and the needle holder 310 seated on the alignment portion 204a may also be formed to be oval in plane cross-section. By doing this, the needle holder 310 After being inserted into the alignment portion 204a, it is possible to prevent the phenomenon from spinning in the circumferential direction, to reliably maintain the aligned state, and to move accurately only in the vertical direction.

The side portion 204b may be formed to have a predetermined length from the end of the housing of the transmitter 200 toward the alignment portion 204a, may be flat rather than curved, and may be formed on both sides of the opening 205. The width, which is the distance between 204b), may be formed to become narrower toward the alignment portion 204a.

The opening 205 may be a portion where a portion of the outer periphery of the housing is cut off, and the opening length of the opening 205 may be formed regardless of whether the needle holder 310 passes through it or not.

In addition, the housing forming the transmitter 200 includes an upper lid 210 and a lower lid 220, and an alignment portion of the depression 204 is provided on the bottom of the upper lid 210 and the upper surface of the lower lid 220, respectively. Guide members 212 and 222 may be formed to protrude in portions corresponding to 204a and the side portion 204b, respectively.

The guide member 212 formed on the bottom of the upper lid 210 may include an alignment guide member 212a formed on the bottom of the alignment portion 204a and a side guide member 212b formed on the side portion 204b. there is.

The guide member 222 formed on the upper surface of the lower lid 210 may include an alignment guide member 222a formed on the bottom of the alignment portion 204a and a side guide member 222b formed on the side portion 204b. there is.

Therefore, when the upper lid 210 and the lower lid 220 are combined, the locking protrusion 211 formed on the edge of the upper lid 210 is inserted into the locking groove 221 formed on the edge of the lower lid 220. It can be combined by losing.

At this time, the guide member 212 formed on the bottom of the upper lid 210 and the guide member 222 formed on the upper surface of the lower lid 220 may be arranged to face each other. Accordingly, the coupling portion 312 of the needle holder 310 inserted into the alignment portion 204a is clearly regulated by the alignment guide members 212a and 222a surrounding the alignment portion 204a and serves as a guide when moving. You can.

In addition, since the alignment protrusion 313 of the needle holder 310 is inserted and disposed between the side guide members 212b and 222b formed on the side portion 204b, a more secure restraint state can be maintained, and the needle 300 ) can serve as a guide when moving.

Additionally, referring to FIG. 11, a locking protrusion 314 may be formed in the needle holder 310 to allow the needle holder 310 to be caught after being inserted into the alignment portion 204a of the recessed portion 204. The locking jaw 314 may be in the form of a circular jaw formed along the circumferential direction of the needle holder 310 and protruding in the radial direction.

In an embodiment of the present invention, when the needle 300 and the transmitter 200 are lowered simultaneously and the needle 300 is inserted into the skin, the alignment portion 204a of the depression 204 is aligned with the needle holder 310. By regulating shaking, the hole pierced in the skin can match the needle diameter and relieve pain.

Since the needle 300 can only move in the vertical direction while being regulated by the alignment portion 204a of the depression 204, it does not move away from the opening 205 along the horizontal direction (radial direction of the housing). This can be fundamentally prevented, and therefore, there is no need to limit the relative size of the width of the center wall portion 302 of the needle 300 and the opening width of the opening 205, and therefore, the needle 300 is larger than the width of the opening 205. The width of the central wall portion 302 of 300 may be formed to be small.

In addition, a communicating portion 204c is formed at the point where the side portion 204b of the depression 204 and the alignment portion 204a meet, and the width of the communicating portion 204c is equal to that of the center wall portion 302 of the needle 300. It can be formed smaller than the width. In this way, when the opening width of the communicating portion 204c is formed to be smaller than the width of the center wall portion 302 of the needle 300, the needle holder 310 provided on the upper part of the needle 300 moves when the needle 300 moves. Even so, the communication part 204c can serve as a guide to achieve an unwavering operation.

The alignment portion 204a, side portion 204b, communication portion 204c, and opening portion 205 forming the recessed portion 204 are the same as the upper lid 210 and lower lid 220 forming the housing of the transmitter 200. can be formed.

The alignment portion 204a, the side portion 204b, and the communication portion 204c forming the recessed portion 204 may all be one side of the housing forming the transmitter 200, and the upper lid 210 and lower lid 220 It may be an outside role.

However, there is no need to be limited to this. The needle holder 310 can be moved in the vertical direction while being guided through the alignment portion 204a and the communication portion 204c.

In other words, the needle holder 310 is formed with a locking groove 311 that is detachably coupled by the driving part 102, and a coupling part 312 having a predetermined length so that the needle 300 is integrally coupled to the lower side. can be formed. A cutout portion 312a through which a portion of the electrochemical sensor 400 passes may be formed on one side of the coupling portion 312.

An alignment protrusion 313 may protrude from one side of the coupling portion 312 to align the needle holder 310 in the correct position when inserted into the alignment portion 204a of the recessed portion 204.

When the needle holder 310 is inserted into the alignment portion 204a of the depression 204, the alignment protrusion 313 passes through the communication portion 204c formed between the alignment portion 204a and the side portion 204b and passes through the side portion 204b. ) can be placed between.

Therefore, since the alignment protrusion 313 can function like a key, the needle holder 310 can be automatically aligned to the correct position when inserted into the alignment portion 204a, and the needle holder 310 can be aligned. When inserted and seated in the alignment unit 204a in the state, the seated state can be reliably maintained without spinning in the circumferential direction, and can operate smoothly only when moved in the vertical direction by the drive unit 102.

The correct position of the needle 300 may be a position where the opening 306 of the needle 300 faces the electrochemical sensor 400. If the needle 300 is not positioned to pass the transmitter 200 in the correct position, the needle 300 may be poorly assembled with respect to the transmitter 200.

Moreover, if the insertion direction of the needle holder 310 is not specified, it is difficult to properly position the needle 300, which may delay device assembly time and result in reduced productivity.

However, the present invention allows you to very easily set the arrangement position of the opening 306 of the needle 300, which is integrally coupled with the needle holder 310 by the alignment protrusion 313 formed in one direction of the needle holder 310. You can.

In other words, when the alignment protrusion 313 is inserted between the side portions 204b from the alignment portion 204a of the recessed portion 204 through the communication portion 204c, the opening portion 306 of the needle 300 is automatically opened. It may be placed toward the electrochemical sensor 400.

Therefore, according to the present invention, the assembly of the needle holder 310 and the needle 300 can be assembled very simply and accurately when assembling the transmitter 200.

Additionally, the alignment portion 204a and the side portion 204b of the recessed portion 204 may be formed continuously.

Additionally, when the housing of the transmitter 200 is circular in plan, the position of the alignment part 204a of the recessed part 204 may be eccentric away from the center.

If the depression 204 is eccentric from the center of the transmitter 200, it can be easy to secure installation space for the main board 202 or electronic components installed inside the transmitter 200, and the transmitter 200 can be miniaturized. can be advantageous.

Since the electrochemical sensor 400 of the present invention has a thin film thickness of 100 micrometers or less, it does not occupy a large thickness when installed inside the transmitter 200, contributing to slimming of the transmitter 200.

A portion of the electrochemical sensor 400 provided inside the transmitter 200 may be disposed to be exposed to the outside of the transmitter 200, and when disposed, the proximal portion 402 and the middle portion 403 of the electrochemical sensor 400 ) (hereinafter referred to as 'embedded portion') is disposed inside the transmitter 200, and a portion of the middle portion 403, the folded portion 405, and the distal portion 406 (hereinafter referred to as 'exposed portion') Can be placed outside the transmitter 200.

A locking piece 403a that functions as a stopper may be formed in the middle portion 403 formed in the electrochemical sensor 400. The locking piece 403a may be formed to be longer in the width direction than the length direction of the middle portion 403 and may be provided in a form that protrudes on both sides of the middle portion 403.

The locking piece 403a can automatically set the alignment position when the exposed portion of the electrochemical sensor 400 is exposed from the housing of the transmitter 200.

The locking portion 403a of the electrochemical sensor 400 is connected to the housing when the exposed portion of the electrochemical sensor 400 is exposed from the embedded portion of the electrochemical sensor 400 provided inside the housing of the transmitter 200 to the outside of the housing. It is possible to provide an appropriate exposure area of the exposed part by hanging it at the exit of the.

The outlet of the housing may be formed in a guide member 222 that protrudes from the depression 204 formed on the upper surface of the lower lid 220. To be more specific, the guide member 222 of the lower lid 220 ) may have an open structure in which the exposed portion of the electrochemical sensor 400 passes between the alignment guide members 222a and the locking piece 403a is caught and aligned without passing through.

The exposed portion of the electrochemical sensor 400 disposed outside the transmitter 200 may be disposed in the recessed portion 204. At this time, the electrochemical sensor 400 is used to insert the electrochemical sensor 400 into the user's skin. ) and the exposed portion of the needle 300 may face each other.

More specifically, the distal portion 406 of the electrochemical sensor 400 may pass through the opening 306 of the needle 300 and be disposed to face the inside of the central wall portion 302 of the needle 300.

In the present invention, the needle 300 may preferably be placed at a specific position rather than being freely placed when moving the recessed portion 204 of the transmitter 200.

That is, the needle 300 includes a center wall portion 302 having a predetermined length, a side wall portion 304 that is bent and protruding on both sides of the center wall portion 302, and a center wall portion ( It may include an opening 306 formed at a position facing the 302).

The opening 306 may be oriented in the direction opposite to the opening 205 of the depression 204 formed in the transmitter 200. When the opening 306 of the needle 300 faces the electrochemical sensor 400, the electrochemical sensor 400 can be inserted without being caught in the side wall 304 of the moving needle 300.

At this time, the folded portion 405 and the distal portion 406 of the electrochemical sensor 400 may be inserted into the internal space between the side wall portions 304 of the needle 300 and placed therein.

When the needle 300 moves, it essentially passes through the recessed portion 204 of the transmitter 200, and the recessed portion 204 may be a structure formed on the outside of the transmitter 200.

In addition, in the present invention, the alignment position of the folded portion 405 of the electrochemical sensor 400 disposed in the depression 204 is referred to as the first alignment position A1, and the alignment position of the needle 300 is referred to as the second alignment position. When defining the position A2, the first alignment position A1 and the second alignment position A2 may be the same position.

In addition, the first alignment position A1 of the electrochemical sensor 400 is disposed within the internal space of the needle 300 consisting of the center wall portion 302 and the side wall portions 304 formed on both sides of the center wall portion 302. It can be. That is, the first alignment position A1 may be arranged to be surrounded by the center wall portion 302 and the side wall portion 304 of the needle 300.

In addition, the folded portion 405 of the electrochemical sensor 400 may be placed in the inner space of the needle 300, and when the folded portion 405 is disposed in the inner space of the needle 300, electricity inserted into the skin There is an advantage that the insertion depth of the chemical sensor 400 is increased.

The transmitter 200 needs to remain waterproof. In particular, the portion where the electrochemical sensor 400 is exposed to the outside from the inside of the housing forming the transmitter 200 must be waterproofed.

When the housing consists of an upper lid 210 and a lower lid 220, the upper lid 210 and the lower lid 220 are each provided with a waterproof member, and a portion of the electrochemical sensor 400 is exposed. When the lid 210 and the lower lid 220 are combined with each other, the waterproof member and a portion of the electrochemical sensor 400 can be waterproofed while being in close contact.

Since the exposed position of the electrochemical sensor 400 is the outer periphery of the upper lid 210 and the lower lid 220, a waterproof member can be installed in a gently curved portion, thereby improving sealing performance.

The waterproof member may include a tape, and in an embodiment of the present invention, a tape for waterproofing may be attached to the upper lid 210 and the lower lid 220, respectively, and may be brought into close contact with a portion of the electrochemical sensor 400. By attaching the tape in multiple layers, adhesion to a portion of the electrochemical sensor 400 can be further increased.

Except for the portion exposed from the housing, the remaining outer peripheral portion of the electrochemical sensor 400 may be sealed using a packing member such as an O-ring or a rubber ring. Since there is no through hole in the transmitter 200, there is only one joint on the outer periphery, so there is an advantage that all joints of the upper lid 210 and the lower lid 220 can be waterproofed with just one O-ring.

Referring to FIG. 10, the position spaced apart from the upper lid 210 and lower lid 220 forming the transmitter 200 is referred to as the first position (P1), and the depression of the upper lid 210 and lower lid 220 When defining the position after moving along the part 204 as the second position (P2), the needle 300 moves from the second position (P2) through the recessed part 204 of the transmitter 200 to the first position ( It can be separated from the transmitter 200 while moving to P1).

In addition, as shown in FIG. 15, the present invention may be provided with a transmitter holder 230 capable of detachably attaching the transmitter 200.

The transmitter holder 230 is provided inside the inserter 100 and moves together with the operation of the inserter 100 to insert the needle 300 provided in the transmitter 200 into the skin.

After inserting the needle 300, when the inserter 100 is moved in a direction away from the skin, the transmitter holder 230 is released from the clamped state of the transmitter 200 and is removed from the skin along with the inserter 100. It can be moved in a spaced direction. At this time, the transmitter 200 remains attached to the skin, and the needle 300 and the needle holder 310 move together with the transmitter holder 230. Therefore, the needle 300 and the needle holder 310 It may be separated from the recessed portion 204 of the transmitter 200.

Here, the transmitter holder 230 includes a body portion 231, a clamping member 232 for clamping the transmitter 200 on one side of the body portion 231, and a needle holder 310 formed at the center of the body portion 231. It may include an insertion hole 233 that is detachably coupled.

The clamping member 232 may include a support member 232a that clamps both sides of the transmitter 200, and a locking protrusion 232b formed on both ends of the support member 232a.

A connection portion 232c connected to the body portion 231 may be formed in the center of the support member 232a, and both sides of the support member 232a based on the connection portion 232c may be provided with a predetermined elastic force. .

The needle 300 penetrates the insertion hole 233, the needle holder 310 is caught, and the guide member 234 supporting the side of the needle holder 310 may protrude.

When the needle 300 and the needle holder 310 are inserted into the insertion hole 233, the needle 300 penetrates and the needle holder 310 is caught,

A support wall 233a protruding from the body portion 231 may be formed around the insertion hole 233.

100... inserter 102... driving unit
200... transmitter 202... main board
204... depression 204a... alignment part
204b... side part 204c... communication part
205... opening
210... Upper lid 211... Catch protrusion
212... guide member 212a... alignment guide member
212b... side guide member
220... Lower lid 221... Locking groove
222... guide member 222a... alignment guide member
222b... side guide member
230... Transmitter holder 231... Body part
232... clamping member 232a... support member
232b... catching protrusion 232c... connection part
233... insertion hole 233a... support wall
234... Absence of guide
300... Needle 302... Center wall portion
304... side wall portion 306... opening portion
310... Needle holder 311... Locking groove
312...joint part 312a...cut part
313... Alignment protrusion 314... Locking protrusion
400... electrochemical sensor 402... proximal
404... middle part 405... folded part
406... Distal
A1... first alignment position A2... second alignment position
P1... 1st position P2... 2nd position

Claims (15)

Electrochemical sensors that penetrate into the skin;
It includes a main board to which a battery is connected and a housing to accommodate the main board, the housing being attached to the skin, and the main board comprising: a transmitter that controls the measured signal of the electrochemical sensor;
A needle that guides the electrochemical sensor to invade into the skin; Including,
the transmitter or needle is moved from a first position to a second position to penetrate the skin of the user,
The proximal part of the electrochemical sensor is electrically connected to the main substrate, and the distal part of the electrochemical sensor is inserted into the skin with the needle,
A continuous analyte measuring device in which a depression is formed in the housing rather than a closed curved surface through which the needle passes and is aligned.
According to claim 1,
The recessed portion is formed by recessing the side of the housing,
A continuous analyte measuring device in which the distal portion and the needle are disposed in the depression.
According to claim 1,
An opening is formed on a side of the housing,
The needle includes an opening into which the electrochemical sensor is inserted,
A continuous analyte meter in which the opening of the needle faces a direction other than the opening.
According to claim 1,
The alignment position of the folded portion of the electrochemical sensor disposed in the depression is referred to as a first alignment position, the alignment direction of the folded portion of the electrochemical sensor is referred to as a first alignment direction, and the alignment position of the needle is referred to as a second alignment position. And when the alignment direction of the needle is defined as the second alignment direction,
the first alignment position and the second alignment position substantially coincide,
The first alignment direction is parallel to the second alignment direction.
According to claim 1,
The needle includes a needle holder,
An opening is formed in a portion of the depression,
The depression is formed at an inner position on the opposite side of the opening, and includes an alignment part that regulates the needle holder from passing through, and side parts corresponding to both sides of the opening.
According to claim 1,
The needle includes a needle holder,
The recessed portion includes an alignment portion that regulates the needle holder from passing through, and a side portion formed on one side of the alignment portion and having a predetermined opening width,
The alignment portion is formed to be larger than the opening width of the side portion.
According to claim 1,
A needle holder is coupled to one side of the needle,
A continuous analyte measuring device provided with a centering means for regulating the coupling position of the needle holder with respect to the transmitter or a rotation prevention means for regulating rotation of the needle holder with respect to the transmitter.
According to claim 1,
A needle holder is coupled to one side of the needle,
A centering means for regulating the coupling position of the needle holder with respect to the transmitter or a rotation prevention means for regulating rotation of the needle holder with respect to the transmitter is provided,
The centering means or the rotation prevention means is provided in at least one of the recessed portion of the transmitter and the needle holder.
According to claim 1,
A needle holder is provided to support the needle,
An alignment protrusion is provided to automatically align the placement position and placement angle of the needle and needle holder with respect to the transmitter,
The alignment protrusion is a continuous analyte measuring device having a shape that protrudes a portion of the needle holder.
According to claim 1,
The needle includes a center wall, side walls formed by bending both sides of the center wall, and an opening formed between the side walls,
A needle holder is coupled to one side of the needle,
The recessed portion includes an alignment portion that regulates the needle holder, a side portion formed on one side of the alignment portion and having a predetermined opening width,
An alignment protrusion is formed on the needle holder to automatically align the placement position and angle of the needle and the needle holder with the transmitter when the needle holder is seated on the alignment unit,
A continuous analyte measuring device in which the placement position and angle of the needle and needle holder are automatically aligned when the alignment protrusion is inserted between the side parts.
According to claim 1,
A needle holder is coupled to one side of the needle,
A centering means for regulating the coupling position of the needle holder with respect to the transmitter or a rotation prevention means for regulating rotation of the needle holder with respect to the transmitter is provided,
The centering means or rotation prevention means includes an alignment portion corresponding to the inside of the recessed portion of the transmitter,
The alignment portion is formed in an oval shape in plan,
The needle holder includes a coupling portion inserted into the alignment portion,
A continuous analyte measuring device wherein the coupling portion has a shape that guides the alignment portion to be inserted into a predetermined position and a shape that regulates the needle holder from rotating in a circumferential direction with respect to the alignment portion.
According to claim 1,
A needle holder is coupled to one side of the needle,
The recessed portion includes an alignment portion that regulates the needle holder, and a side portion formed on one side of the alignment portion and having a predetermined opening width,
The side portion is formed to have a predetermined length from the end of the housing of the transmitter toward the alignment portion,
The side portion is a continuous analyte measuring device that is flat.
According to claim 1,
A continuous analyte measuring device in which the depression is formed at an eccentric position outside the center of the housing.
According to claim 1,
The housing is,
upper lid,
It includes a lower lid coupled to the upper lid,
The depression is formed in the upper lid and the lower lid,
When the upper lid and the lower lid are combined, the depressions are arranged to coincide with each other.
According to claim 1,
The housing is,
upper lid,
It includes a lower lid coupled to the upper lid,
The depression is formed in the upper lid and the lower lid,
A guide member protrudes from the bottom of the upper lid and the upper surface of the lower lid at a position corresponding to the depression, respectively,
A continuous analyte measuring device in which the needle holder is regulated and guided in vertical movement by the guide member.

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